This invention relates to medical apparatus generally, and more specifically it relates to an improved device for retention of an endotracheal tube in proper position on a patient, with convenience to the technician, comfort to the patient, and versatility in the ability to relocate the endotracheal tube periodically as needed.
In respiratory therapy, endotracheal tube therapy is a necessary but usually highly uncomfortable part of a patient's treatment. It has been typical and conventional practice to tape these endotracheal tubes on the patient, in a position intended to hold the tube properly in the patient's throat. In oral intubation, this usually requires that the tube be secured up toward the top of the mouth, generally against the palate and to one side of the mouth in order to allow the tongue some freedom. The tube must be held in a stable manner for comfort to the patient and effectiveness of the tube therapy.
There has generally not been a uniform method for securing the tubes in place, and different therapists have followed different practices in taping the tube to the patient. Sometimes these retention arrangements are effective and sometimes not, but in nearly all cases, the taped-in tube is uncomfortable to the patient and limited in effectiveness.
Further, there is ordinarily a need to change the tape quite frequently, for several reasons including resecuring of the tube in the proper position, discomfort of the patient and avoidance of lesions on the skin.
It is rather critical that the endotracheal tube be held at the correct level in the throat and at the right position. If the tube is central and extends too far down the throat, it may enter the right main stem bronchus, resulting in irritation and one-sided ventilation. If the tube does not extend far enough down the patient's throat, then it may not make a proper seal and it may pull out of the throat, preventing its effectiveness. Generally, the lower end of the endotracheal tube should extend to a point about three to five centimeters above the carina or bronchial bifurcation for best results. A radiopaque dye line in the tube allows the use of X-ray for locating the tube.
A number of attempts have been made previously to remedy these problems and to provide retaining devices for endotracheal tubes which will hold the tube securely and reliably in the correct position. Previous U. S. Pats. on this subject include Andrew Pat. Nos. 3,602,227 and 3,760,811, Cussell Patent No. 3,993,081, Nestor Patent No. 4,249,529, Hall Patent No. 4,284,076, Gereg Patent No. 4,351,331, George Patent No. 4,392,858, Hinton Patent No. 4,449,527, Clair Patent No. 4,483,337, Laird Patent No. 4,683,882 and McGinnis Patent No. 4,744,358.
Nearly all of the devices proposed in these patents would be highly uncomfortable to the patient, and most involve bulky apparatus for engaging the tube and for connecting to the patient. Some of the proposed apparatus would block the patient's mouth excessively (on oral intubation), would result in lesions developing on the patient's skin, would apply pressure due to the use of elastic, would prevent nearly all freedom of movement of the patient, or in some cases, would not be effective in holding the tube in the proper position.
The Hinton patent discloses an endotracheal tube retention system including a tube-engaging clamp and a strap which connects to both sides of the clamp via snap fasteners. The strap is in two pieces with a Velcro connection at the back to provide adjustable head size. However, the device of the Hinton patent would not secure the endotracheal tube near the top of the mouth, as is most desirable. If the elastic headband were tightened, it would tend to draw the clamp device back against the mouth, not toward the top of the mouth. In addition, the interior of Hinton's clip was of spongy material, which should be avoided for hygiene reasons. Further, the clamp device of the patent would significantly obstruct the patient's mouth at the lower side of the tube.
The Laird patent shows a somewhat similar endotracheal tube retaining apparatus, with a short strip of adhesive for engaging the patient's face. The tube engaging clamp of that patent is so bulky as to provide excessive obstruction of the mouth.
In the Nestor patent, a pair of bands are disclosed for extending around the back of the head, but the important upper band would tend to slip down, changing the position of tube retention. Further, the tube securing clamp device of this patent was of excessive size, engaging a large portion of the patient's upper lip and face and tending to obstruct the patient's mouth.
The endotracheal tube holder disclosed in the Cussell patent involved a large, obstructing clamp and adhesive tape applied to the upper lip of the patient, which is undesirable for comfort of the patient and reliability of the tube position.
The Andrew patents disclose endotracheal tube clamp structures which are large and obstructive and would tend not to secure the tube toward the patient's palate or maxillary as is desirable. Discomfort would be caused by rigid materials against or near the patient.
The Clair patent disclosed another endotracheal tube retainer which would seem to require a special tube end, which would not secure the tube upwardly toward the palate or maxillary and which would provide a hard line of contact against the patient's mouth.
The McGinnis device was quite bulky in obstructing the mouth and in requiring a relatively large and complex head gear for holding the tube in place.
The Gereg patent disclosed a tube holder which included a bite block and provision for connection around the ears. This would tend to cause discomfort and lesions on the patient.
As is clear from a review of these previous patents, the prior art has failed to adequately address a number of problems: maximizing comfort to the patient; proper retention of the endotracheal tube upwardly near or against the palate or maxillary; minimization of size of tube retention structure at the patient's mouth and face so as to maximize the ability of the patient to use the mouth; effectiveness in engaging the head and in holding the tube properly; ease of changing the headband retention structure; and avoidance of any rigid parts against the patient's upper lip. These problems are all addressed in an efficient device according to the present invention described below.